NvisionVLE Marking Console Refurbished
The listed NvisionVLE Console is a component of the NvisionVLE Imaging System, a high-resolution volumetric imaging platform based on optical coherence tomography. It acquires…
The listed NvisionVLE Console is a component of the NvisionVLE Imaging System, a high-resolution volumetric imaging platform based on optical coherence tomography. It acquires cross-sectional, real-time tissue images.
The filing describes a mobile NvisionVLE Console with an integrated computer and two touch-screen interfaces. The console is part of the system’s imaging and tissue-marking platform.
Imaging and Marking
The broader platform includes NvisionVLE software, a single-use marking probe, and an inflation system. Its integrated 1470 nm laser creates temporary marks on tissue areas identified through VLE imaging.
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Ninepoint Medical, Inc., United States |
|---|---|
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| 510(k) | K153479 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 60 °C; Handling environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 94301-M-R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Optis™ | Lightlab Imaging, Inc. | 11 |
| Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 9 |
| Ilumien™ | Lightlab Imaging, Inc. | 6 |
| Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device&Technology Co., Ltd. | 2 |
| VivoSight | Michelson Diagnostics Ltd | 2 |
| AptiVue™ | Lightlab Imaging, Inc. | 2 |
| Pantheris | Avinger, Inc. | 2 |
| NvisionVLE Imaging Console | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Imaging Console Refurbished | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Marking Probe 17mm | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | Ninepoint Medical, Inc. | 1 |
Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191117 | 2019-07-19 |
| K182616 | 2018-11-02 |
| K182261 | 2018-10-16 |
| K153479 | 2016-02-16 |
| K143678 | 2015-02-06 |
| K120800 | 2013-04-25 |
| K121195 | 2012-07-25 |
| K112770 | 2011-12-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-04-11 | Class II | Process control | Distal tips of the probes may detach from the probe shaft during use. | 152 | 2018-08-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.